Reliable Quality Assurance in Medical Technology

Tight tolerances, strict regulations in accordance with ISO 13485 and MDR as well as the challenge of complex shapes and surfaces - the demands on quality assurance in medical technology are high. Absolute precision counts here!

With state-of-the-art optical 3D measurement technology, Bruker Alicona offers you the perfect solution to achieve these high standards. Find out how our innovative optical measurement technologies help you to make quality assurance efficient and reliable - for medical products that combine safety and precision. Because when it comes to health and safety, there are no compromises.

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Innovative Solutions for Precision in Medical Technology

Orthopaedic Implants

Modern implants, such as hip or knee implants, generally have complex geometries with steep flanks and sometimes highly polished surfaces. Different roughness properties in implants, depending on the age and physical condition of the patient, are essential for optimal integration with the body. This is the only way to ensure that the implant is not perceived as a foreign body. In addition to roughness measurement, the verification of GD&T parameters is also becoming increasingly important. Optical 3D metrology offers fast, non-destructive analysis and high measurement reliability.

Bone Screws

Bone screws are used to stabilize bones during surgery, either alone or together with other devices such as plates. Their precise design is crucial for safe and effective surgical procedures, as it ensures minimal damage during insertion and reduces risks for the patient. Focus-Variation technology enables accurate verification of key parameters such as radii, distances, angles, diameters and pitches with minimal measurements, supporting the highest standards of surgical precision and patient safety.

Tooth Implants

The optimal integration of a dental implant into the jawbone requires precise measurements of both surface roughness and shape. Specialized blasting and etching techniques ensure uniform roughness distribution, which is crucial for effective protein binding and seamless integration with the jawbone. Focus-Variation technology provides detailed Sa, Sq and Sz values over the thread flanks and roots and evaluates the surface quality with high accuracy. Shape measurements also ensure a secure fit between the implant and the prosthetic restoration, guaranteeing optimal functionality and patient comfort.

Surgical Instruments

Surgical instruments are essential for precise medical procedures and require accurate measurements of cutting edges with the smallest radii, various tool geometries, cutting angles, edge integrity and burr formation. Optical metrology provides precise, non-contact measurements that are critical to maintaining sharpness, durability and effectiveness. By using advanced optical metrology, healthcare professionals ensure that surgical instruments meet rigorous standards, optimizing surgical outcomes and patient safety.

Quality Assurance for Additively Manufactured Medical Devices

Additive manufacturing, also known as 3D printing, is a modern process used to create complex and customized components. This process plays a crucial role in the manufacture of patient-specific medical devices. Here too, Bruker Alicona offers solutions to ensure the high quality of additively manufactured medical implants. Measurement technology plays an important central role in all process steps of the production chain - both in production and for the final inspection of the manufactured component. The focus here is mainly on roughness measurement. In addition, geometric features such as internal structures, different wall thicknesses, free-form surfaces or structures in very small sizes must also be verified.